High Fresh Gas Flow After Intubation
High Fresh Gas Flow After Intubation - A Randomized Clinical Trial
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Västmanland
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Köping, Västmanland, Sverige, 731 30
- Landstinget Västmanland
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy patients, American Society of Anesthesiology (ASA) I-II
- Patients scheduled for orthopaedic day case surgery in general anaesthesia
Exclusion Criteria:
- ASA class III or higher
- Body Mass Index (BMI) 30 or higher
- Arterial oxygen saturation (SpO2) <94% breathing air
- Chronic Obstructive Pulmonary Disease (COPD)
- Ischemic heart disease
- Haemoglobin <100g/L
- Known or anticipated difficult airway and/or intubation
- Active smokers and ex-smokers with a history of more than 6 pack years
- Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Control group, conventional ventilatory settings
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. |
Handling of the airway during induction and intubation is performed in a conventional manner. Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. |
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Aktiv komparator: High fresh gas flow, high minute ventilation
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver. |
Handling of the airway during induction and intubation is performed in a conventional manner. Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Atelectasis
Tidsramme: Within 1-2 hours, just before emergence from anesthesia
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The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.
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Within 1-2 hours, just before emergence from anesthesia
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Arterial blood gases
Tidsramme: Within 2-3 hours perioperatively
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Within 2-3 hours perioperatively
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Mats Enlund, MD, PhD, Landstinget i Värmland
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Dnr 2012/335
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